Muscle Dysfunction in Gastrointestinal or Hepatobiliary Cancer

Cancer Clinical Trial

Official title:

Prognostic Role of Muscle Dysfunction in Patients With Gastrointestinal or Hepatobiliary Cancer - An Observational Study of Two Patient Cohorts

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03347162
• Other study ID #: MuscleLab1.0
• Status: Active, not recruiting
• Start date: December 1, 2017
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

PURPOSE: To determine the prognostic properties of a comprehensive evaluation of body composition and physical function in patients with GI-HEP cancer from point of diagnosis and throughout the treatment trajectory.

GI-HEP: Patients with tumors of the upper gastrointestinal or hepatobiliary tract, specifically tumors of the esophagus, gastro-esophageal junction, stomach, primary tumors of the liver or biliary tract, as well as colorectal liver metastasis or tumors of the pancreas.

Description:

RATIONAL: Patients diagnosed with GI-HEP cancer are faced with poor prognosis. The treatment is demanding and associated with severe deconditioning potentially leading to worse prognostic outcomes. To what extend patients body composition at the point of diagnoses, as well as changes in body composition throughout the cancer continuum is associated with cancer outcomes is currently not well-described, specifically if this should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with histologically verified GI-HEP cancer

Exclusion Criteria:

• Age: <18

• Pregnancy

• Physical or mental disabilities precluding physical testing

• Inability to read and understand Danish

Related Conditions & MeSH terms

• Cancer
• Cancer of Esophagus
• Cancer of Liver
• Cancer of Pancreas
• Cancer of Stomach
• Cancer, Metastatic
• Esophageal Neoplasms
• Liver Neoplasms
• Pancreatic Neoplasms
• Stomach Neoplasms

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1: Post-operative complications	Incidens rate of post-operative complications (Clavien-Dindo grade 2 or higher).	From baseline to 30 days post surgery
Primary	Cohort 2: Medical treatment complications	Incidens rate of medical complications (dose-reduction, temporary or permanent discontinuation)	From baseline to 1 year follow-up
Secondary	Hospitalization duration	Total number days in hospital	From baseline to 1 year follow-up
Secondary	Disease free survival	Risk of disease progression	From baseline to 1 year follow-up
Secondary	Overall survival	Risk of mortality from any-cause	From baseline to 1 year follow-up
Secondary	Change in whole body lean mass	Dual-energy X-ray Absorptiometry (DXA) scan	From baseline to 6 months follow-up
Secondary	Change in appendicular lean mass	Dual-energy X-ray Absorptiometry (DXA) scan	From baseline to 6 months follow-up
Secondary	Change in whole body fat percentage	Dual-energy X-ray Absorptiometry (DXA) scan	From baseline to 6 months follow-up
Secondary	Change in visceral fat mass	Dual-energy X-ray Absorptiometry (DXA) scan	From baseline to 6 months follow-up
Secondary	Change in bone mineral density	Dual-energy X-ray Absorptiometry (DXA) scan	From baseline to 6 months follow-up
Secondary	Change in bone mineral content	Dual-energy X-ray Absorptiometry (DXA) scan	From baseline to 6 months follow-up
Secondary	Change in Skeletal Muscle Index	L3 muscle area determined by Computed tomography scan (performed for clinical purpose) adjusted for hight	From baseline to 6 months follow-up
Secondary	Change in Walking capacity	Maximum 10 meter walking speed	From baseline to 6 months follow-up
Secondary	Change in stair-climbing capacity	Timed Stair-climbing test	From baseline to 6 months follow-up
Secondary	Change in lower body physical function	30 seconds Sit-To-Stand test	From baseline to 6 months follow-up
Secondary	Change in maximum leg power	Leg extensor power test (Nottingham Power rig)	From baseline to 6 months follow-up
Secondary	Change in hand grip strength	Maximum strength test by handgrip dynanometer	From baseline to 6 months follow-up
Secondary	Change in plasma total cholesterol concentration	Blood sample	From baseline to 6 months follow-up
Secondary	Change in plasma HDL cholesterol	Blood sample	From baseline to 6 months follow-up
Secondary	Change in plasma LDL cholesterol	Blood sample	From baseline to 6 months follow-up
Secondary	Change in plasma triglycerides	Blood sample	From baseline to 6 months follow-up
Secondary	Change in plasma HbA1C	Blood sample	From baseline to 6 months follow-up
Secondary	Change in plasma glucose	Blood sample	From baseline to 6 months follow-up
Secondary	Change in plasma insulin	Blood sample	From baseline to 6 months follow-up
Secondary	Change in health-related quality of life	Functional Assessment of Cancer Therapy (FACT) questionnaire	From baseline to 6 months follow-up
Secondary	Change in psychological distress	Hospital Anxiety and Depression Scale (HADS) questionnaire	From baseline to 6 months follow-up
Secondary	Change in sleep quality	Pittsburgh Sleep Quality Index (PSQI) questionnaire	From baseline to 6 months follow-up
Secondary	Change in physical activity level	International Physical Activity Questionnaire (IPAQ) short form	From baseline to 6 months follow-up